NCT03134768

Brief Summary

The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 19, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 26, 2017

Results QC Date

March 5, 2020

Last Update Submit

April 1, 2020

Conditions

Immunologic Activity Alteration

Outcome Measures

Primary Outcomes (3)

  • Cytokines Profile in Cord Blood Plasma

    Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa

    1 year

  • Cord Blood Immunoglobulin Levels

    Immunoglobulin levels will be measured in cord blood plasma

    1 year

  • Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)

    Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.

    1 year

Interventions

This is not an interventional studyOTHER

This is an observational study

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant mothers
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant mothers undergoing normal vaginal delivery

You may qualify if:

  • Pregnant mothers undergoing normal vaginal delivery

You may not qualify if:

  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth
  • Antenatal antibiotics treatment (2 weeks prior to birth)
  • Diabetes mellitus requiring insulin treatment during pregnancy
  • Uncontrollable Hyperthyroidism during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

cord blood

Results Point of Contact

Title
Dr Elena Sandalova
Organization
Danone Nutricia Research
elena.sandalova@danone.com
6568309433

Study Officials

  • Elena Sandalova, PhD

    Danone Asia Pacific Holdings Ltd

    STUDY CHAIR

  • Anne Goh, MD

    KK Hospital

    STUDY CHAIR

  • Mei Chin Chua, MD

    KK Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

May 2, 2016

Primary Completion

November 16, 2016

Study Completion

October 12, 2017

Last Updated

April 3, 2020

Results First Posted

March 19, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share